Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites. A Multicentre Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year).
研究概览
简要总结
Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All patients will receive medical care for cirrhosis and ascites according to the institution's standards of care. Standard of care may include, but is not limited to the administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
详细描述
The study will include patients with decompensated liver cirrhosis and recurrent or refractory, with regular requirements for large volume paracentesis (see subject inclusion criteria). With respect to TIPS-contraindications patients will be assigned to two substudies. If no TIPS-contraindications exists (sub-study 1) patients will be randomized to Alfapump or TIPS. The presence of at least one TIPS-contraindication (sub-study 2) is leading to a randomization to Alfapump or standard of care. All patients will receive medical care for cirrhosis and ascites according to the institution's standards medical care. Standard of care may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of the liver
- •Recurrent or refractory ascites
- •Age ≥ 18 years (at informed consent)
- •Written informed consent
- •Expected ability to operate the Alfapump device
- •Alcohol abstinence ≥ 3 months at date of inclusion
排除标准
- •General contraindications indicating an advanced stage of liver cirrhosis:
- •Bilirubin > 5 mg/dl and/or
- •INR > 1.5 (without oral anticoagulant such as Vitamin K antagonists or new oral anticoagulants (NOAKs), which inhibit the determination of INR. Therefore patients must be switched to alternative anticoagulants such as heparin or low molecular heparin or fondaparinux that do not interfere with INR measurements) and/or
- •Serum-Sodium < 130 mmol/l and/or
- •ECOG > 2 (Performance status)
- •Gastrointestinal haemorrhage during the last 7 days before inclusion
- •Renal failure defined as serum creatinine higher than or equal to 1,5 mg/dl at time of inclusion
- •Clinical evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks before inclusion.
- •Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks before inclusion.
- •Clinical evidence of loculated ascites.
- •Residual urinary volume exceeding 100 ml if obstructive uropathy is known or suspected
- •Known bladder anomaly which might contraindicate implantation of the device.
- •Known or suspected hepatic or extra hepatic malignancy, unless adequately treated and in complete remission for ≥ 3 years
- •Known active chronic hepatitis C (unless adequately treated, i.e no Virus-RNA detectable after cessation of antiviral treatment)
- •Acute peritonitis
- •Pregnant or nursing women. (A serum pregnancy test is required for fertile women within two years of their last menstruation.)
- •Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implantation, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
- •Suspected lack of compliance
- •Patients enrolled in another interventional clinical study
研究组 & 干预措施
Alfapump - Substudy 1
Alfapump implantation
干预措施: Alfapump (Device)
TIPS - Substudy 1
TIPS implantation
干预措施: TIPS (Device)
Alfapump - Substudy 2
Alfapump implantation
干预措施: Alfapump (Device)
Standard - Substudy 2
Standard treatment
结局指标
主要结局
The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year).
时间窗: Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.
次要结局
- Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.(Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
- Transplant-free survival(From randomisation to 24 months or to death, censoring patients alive at the date of last information or at the date of orthotopic liver transplantation.)
- Cumulative Incidence of device abandonment(Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
- Nutrition status, assessed by time course of upper arm girth [cm](Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
- Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.(Starts with randomisation and ends after 24 months or when a device abandonment, transplant, or death occurs before.)
- Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher(Starts with randomisation and ends after 12 months months or when a device abandonment, transplant, or death occurs before.)
- Volume of ascites removed(Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.)
- Albumin substitution, assessed as total amount per quarter [g].(Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
- Patients Quality of Life (EQ-5D Questionnaire)(Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
- Frequency and duration of hospital stays(Starts with randomisation and ends after 24 months or when transplant or death occurs before.)
研究者
Cornelius Engelmann
Dr. med.
University of Leipzig